To measure the rates and predictors of mortality, loss to follow-up, and immunologic failure among adults receiving antiretroviral therapy (ART).

Setting

Nineteen HIV-specific and general public and private health clinics formed initially as two research cohorts in Côte d'Ivoire that merged into a HIV care and treatment program at the completion of the study.

Study Design

Prospective cohort.

Participants

HIV-infected patients who received care at one of the clinics.

Outcomes

Death, lost to follow-up, immunologic failure.

Methods

HIV-specific care was provided at the 19 clinics according to standard protocols and was recorded using standardized data collection forms. All patients had CD4 cells measured biannually. ART was initiated among patients with WHO clinical stage 4 disease, CD4 count <200 cells/mm3, or clinical stage 3 and CD4 count between 200 and 350 cells/mm3. Cotrimoxazole prophylaxis was provided to patients with CD4 count <500 cells/mm3. Patients who missed their scheduled appointments received telephone calls or home visits by a community-based team.

Patients who had ever used ART were considered lost to follow-up if their last contact with the clinic was at least three months prior to February 1, 2007, if they were not known to have died before this date. Immunological failure was defined as a difference between the baseline and six month CD4 count of <50 cells. Baseline was the date of ART initiation. Patients not known to have died were censored on February 1, 2007 or at the last date of contact at the clinic. Cox proportional hazards models were used to examine the association between demographic characteristics, clinical markers, choice of ART, type of clinic, and the medication possession ratio, which was defined as the number of days of treatment given to the patient at the pharmacy during the study period divided by the time between ART initiation and last clinic visit. Patients still living at six months were included in a multivariable logistic regression model to assess the association between demographic and clinical explanatory variables and immunologic failure. The probability of death based on CD4 counts before starting ART and the probability of being lost to follow-up based on the type of clinic (HIV-specific or not) were estimated using the Kaplan-Meier product limit method.

Results

Between May 2004 and February 1, 2007, 10,211 patients initiated ART. The median baseline CD4 count was 123 cells cells/mm3, median body mass index (BMI) was 19.1 kg/m2, and 81% were at WHO clinical stage 3 or 4. Patients were followed for a median of 7.7 months (interquartile range [IQR] 2.6-15.5). The overall median MPR was 0.98 (IQR 0.78-1.00). At the end of the study, 14% of patients who initiated ART were lost to follow-up.

The 18-month probability of death was 0.15 and the probability of being lost to follow-up was 0.21. Survival was worse with lower baseline CD4 cell counts. The probability of being lost to follow-up was lower for patients seen at the HIV-specific clinic. The median gain in CD4 cells following initiation of ART was 136 cells (IQR 71-218) at six months, 166 (IQR 84-249) at 12 months, and 202 (IQR 107-314) at 18 months among patients followed for those periods.

The risk of death was significantly increased among men; older persons; those with lower baseline CD4 cell counts, higher WHO clinical stage, lower hemoglobin levels and lower BMI; and among patients receiving care at the general, not HIV-specific, clinics. The risk of being lost to follow-up was greater among men and those with higher clinical stage, lower hemoglobin levels, and who were receiving care at the general clinic. The likelihood of a gain of <50 cells was higher among men and those with lower baseline CD4 counts, lower hemoglobin levels, and with an MPR of <80%.

Conclusions

Rapid scale-up of ART in a resource limited area that uses general health clinics resulted in survival rates similar to those in other studies.(1,2) The high proportion of patients who were lost to follow-up suggests a need for HIV care clinics to establish methods to enhance continuity of care. Follow-up, survival, and immune reconstitution were better at the HIV-specific clinic.

Quality Rating

This study is of fair quality. The cohort included patients at nongovernmental clinics, including those not dedicated solely to HIV care, which makes the findings generalizable. Baseline data were complete; however, the paper does not describe how deaths were ascertained. Studies that have traced patients lost to follow-up found that a large proportion had died.(3) It is therefore likely that survival was overestimated. Several of the statistical methods used in the study were not described by the authors.

In Context

HIV care and treatment programs require real-time, exact information on the number of patients in care, number lost to follow-up, and outcome measures of treatment in order to effectively plan for care and treatment services and to evaluate the success of their programs.

Programmatic Implications

This study demonstrates that rapid scale-up of HIV care programs can result in reasonably good clinical outcomes. The use of general health clinics is likely to be a key factor in rapid scale-up; however, the outcomes from these clinics were not as good as those from the HIV-specific clinic. Enhanced training, follow-up, back-up, and support for clinics not entirely devoted to HIV care should be considered and, if implemented, carefully evaluated.